Byetta

"Researchers have begun the first definitive, large-scale clinical trial to investigate if a vitamin D supplement helps prevent or delay type 2 diabetes in adults who have prediabetes, who are at high risk for developing type 2. Funded by the N"...

For Patients

Byetta (exenatide) is an injectable diabetes medicine that helps control blood sugar levels. Exenatide is used to treat type 2 (non-insulin dependent) diabetes. It is administered as a subcutaneous injection. Side effects can include nausea, vomiting, weight loss, heartburn, dizziness, or headache. Other side effects may occur.

There are no adequate and well-controlled studies of Byetta use in pregnant women, but in animal studies, exenatide caused cleft palate, irregular skeletal ossification and an increased number of neonatal deaths. It is not known whether exenatide is excreted in human milk.

Our Byetta Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Nausea, vomiting, diarrhea, nervousness, or upset stomach may occur as your body adjusts to the medication. Nausea usually lessens as you continue to use exenatide. Other side effects include decreased appetite or weight loss. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Although exenatide by itself usually does not cause low blood sugar (hypoglycemia), low blood sugar may occur if this drug is prescribed with other anti-diabetic medications. Talk with your doctor or pharmacist about all your diabetic medication(s).

Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor about the reaction immediately. Low blood sugar is more likely if you drink large amounts of alcohol, do unusually heavy exercise, or do not consume enough calories from food. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Talk with your doctor or pharmacist about what to do if you miss a meal.

Stop taking exenatide and tell your doctor right away if any of these very serious side effects occur: signs of pancreatitis (such as persistent nausea/vomiting, loss of appetite, severe stomach/abdominal/back pain), a change in the amount of your urine.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

SIDE EFFECTS

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse
reaction rates observed in the clinical trials of a drug cannot be directly
compared to rates in the clinical trials of another drug and may not reflect
the rates observed in practice.

Hypoglycemia

Table 1 summarizes the incidence and rate of hypoglycemia with BYETTA (exenatide injection) in five placebo-controlled clinical trials.

Table 1: Incidence (%) and Rate of Hypoglycemia When BYETTA (exenatide injection)
was Used as Monotherapy or With Concomitant Antidiabetic Therapy in Five Placebo-Controlled
Clinical Trials*

BYETTA

Placebo twice daily

5 mcg twice daily

10 mcg twice daily

Monotherapy (24 Weeks)

N

77

77

78

% Overall

1.3%

5.2%

3.8%

Rate (episodes/patient­year)

0.03

0.21

0.52

% Severe

0.0%

0.0%

0.0%

With Metformin (30 Weeks)

N

113

110

113

% Overall

5.3%

4.5%

5.3%

Rate(episodes/patient­year)

0.12

0.13

0.12

% Severe

0.0%

0.0%

0.0%

With a Sulfonylurea (30 Weeks)

N

123

125

129

% Overall

3.3%

14.4%

35.7%

Rate (episodes/patient­year)

0.07

0.64

1.61

% Severe

0.0%

0.0%

0.0%

With Metformin and a Sulfonylurea (30 Weeks)

N

247

245

241

% Overall

12.6%

19.2%

27.8%

Rate(episodes/patient­year)

0.58

0.78

1.71

% Severe

0.0%

0.4%

0.0%

With a Thiazolidinedione (16 Weeks)

N

112

Dose not studied

121

% Overall

7.1%

Dose not studied

10.7%

Rate(episodes/patient-years)

0.56

Dose not studied

0.98

% Severe

0.0%

Dose not studied

0.0%

* For the 30-week trials, a hypoglycemia
episode was recorded if the patient reported symptoms consistent with
hypoglycemia and was recorded as severe if the subject required the assistance
of another person to treat the event. For the other trials, a hypoglycemic
episode was recorded if a patient reported signs or symptoms of hypoglycemia
or had a blood glucose value consistent with hypoglycemia regardless of
associated symptoms or treatment and was recorded as severe if the subject
required the assistance of another person to treat the event. The requirement
for assistance had to be accompanied by a blood glucose measurement of
< 50 mg/dL or prompt recovery after administration of oral carbohydrate.
N = The number of Intent-to-Treat subjects in each treatment group.

Immunogenicity

In the 30-week controlled trials of BYETTA (exenatide injection) add-on to metformin and/or sulfonylurea,
38% of patients had low titer antibodies to exenatide at 30 weeks. For this
group, the level of glycemic control (hemoglobin A1c [HbA1c]) was generally
comparable to that observed in those without antibody titers. An additional
6% of patients had higher titer antibodies at 30 weeks. In about half of this
6% (3% of the total patients given BYETTA (exenatide injection) in the 30-week controlled studies),
the glycemic response to BYETTA (exenatide injection) was attenuated; the remainder had a glycemic
response comparable to that of patients without antibodies.

In the 16-week trial of BYETTA (exenatide injection) add-on to thiazolidinediones, with or without
metformin, 9% of patients had higher titer antibodies at 16 weeks. In the 24-week
trial of BYETTA (exenatide injection) used as monotherapy, 3% of patients had higher titer antibodies
at 24 weeks. Compared with patients who did not develop antibodies to BYETTA (exenatide injection) ,
on average the glycemic response in patients with higher titer antibodies was
attenuated [see WARNINGS AND PRECAUTIONS].

Other Adverse Reactions

Monotherapy

For the 24-week placebo-controlled study of BYETTA (exenatide injection) used as a monotherapy, Table
2 summarizes adverse reactions (excluding hypoglycemia) occurring with an incidence
≥ 2% and occurring more frequently in BYETTA (exenatide injection) -treated patients compared with
placebo-treated patients.

Adverse reactions reported in ≥ 1.0 to < 2.0% of patients receiving BYETTA (exenatide injection)
and reported more frequently than with placebo included decreased appetite.
Nausea was the most frequently reported adverse reaction and occurred in a dose-dependent
fashion. With continued therapy, the frequency and severity decreased over time
in most of the patients who initially experienced nausea. Patients in the long-term
uncontrolled open-label extension studies at 52 weeks reported no new types
of adverse reactions than those observed in the 30-week controlled trials.

The most common adverse reactions leading to withdrawal for BYETTA (exenatide injection) -treated
patients were nausea (3% of patients) and vomiting (1%). For placebo-treated
patients, < 1% withdrew due to nausea and none due to vomiting.

Add-on to thiazolidinedione with or without metformin

For the 16-week placebo-controlled study of BYETTA (exenatide injection) add-on to a thiazolidinedione,
with or without metformin, Table 4 summarizes the adverse reactions (excluding
hypoglycemia) with an incidence of ≥ 2% and occurring more frequently in BYETTA (exenatide injection) -treated
patients compared with placebo-treated patients.

Table 4: Treatment-Emergent Adverse Reactions ≥ 2% Incidence
With BYETTA (exenatide injection) Used With a Thiazolidinedione, With or Without Metformin (Excluding
Hypoglycemia)*

With a TZD or TZD/MET

Placebo
N = 112
%

All BYETTA (exenatide injection) BID
N = 121
%

Nausea

15

40

Vomiting

1

13

Dyspepsia

1

7

Diarrhea

3

6

Gastroesophageal Reflux Disease

0

3

* In a 16-week placebo-controlled clinical
trial.
BID = twice daily.

Adverse reactions reported in ≥ 1.0 to < 2.0% of patients receiving BYETTA (exenatide injection)
and reported more frequently than with placebo included decreased appetite. Chills (n = 4) and injection-site reactions (n = 2) occurred only in BYETTA (exenatide injection) -treated
patients. The two patients who reported an injection-site reaction had high
titers of antibodies to exenatide. Two serious adverse events (chest pain and
chronic hypersensitivity pneumonitis) were reported in the BYETTA (exenatide injection) arm. No serious
adverse events were reported in the placebo arm.

The most common adverse reactions leading to withdrawal for BYETTA (exenatide injection) -treated
patients were nausea (9%) and vomiting (5%). For placebo-treated patients, < 1%
withdrew due to nausea.

Post-Marketing Experience

The following additional adverse reactions have been reported during post-approval
use of BYETTA (exenatide injection) . Because these events are reported voluntarily from a population
of uncertain size, it is generally not possible to reliably estimate their frequency
or establish a causal relationship to drug exposure.